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Dear all
The EGA (European Generic Association) sent a letter to the CMDh asking for a clarified joint statement by the EMA PKWP and the CMDh regarding the retrospective application of the bioanalytical method validation guideline for all studies performed (and completed) before finalisation of the guideline and already part of approved dossiers. As a reply CMDh is saying ‘indeed, it is under discussion’. In other words, they do not want to involve anybody in the discussion at this stage.
However, once you received a marketing authorisation for a product you will not have to withdraw the product if your study submitted with the dossier is not compliant with the current guideline. In my opinion if you run a repeat use procedure your original MA should not be in danger of being revoked. Otherwise in this sense all marketing authorisation for generic products would be affected by the new guideline on method validation and this can not be. As stated by the CMDh this is only applicable for applications submitted after February this year.
I hope this helps.
Kind regards
Dan
The EGA (European Generic Association) sent a letter to the CMDh asking for a clarified joint statement by the EMA PKWP and the CMDh regarding the retrospective application of the bioanalytical method validation guideline for all studies performed (and completed) before finalisation of the guideline and already part of approved dossiers. As a reply CMDh is saying ‘indeed, it is under discussion’. In other words, they do not want to involve anybody in the discussion at this stage.
However, once you received a marketing authorisation for a product you will not have to withdraw the product if your study submitted with the dossier is not compliant with the current guideline. In my opinion if you run a repeat use procedure your original MA should not be in danger of being revoked. Otherwise in this sense all marketing authorisation for generic products would be affected by the new guideline on method validation and this can not be. As stated by the CMDh this is only applicable for applications submitted after February this year.
I hope this helps.
Kind regards
Dan
—
Kind regards and have a nice day
Dr_Dan
Kind regards and have a nice day
Dr_Dan
Complete thread:
- ISR The Outlaw Torn 2012-11-29 15:58
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- ISRDr_Dan 2012-11-29 16:30
- ISR The Outlaw Torn 2012-11-30 07:53
- ISR Ohlbe 2012-12-17 22:53
- ISR The Outlaw Torn 2012-12-18 08:09
- 90% CI riddle Helmut 2012-12-18 17:12
- 90% CI riddle The Outlaw Torn 2012-12-19 07:49
- 90% CI riddle Dr_Dan 2012-12-20 09:45
- 90% CI riddle The Outlaw Torn 2012-12-20 11:23
- 90% CI riddle Dr_Dan 2012-12-20 12:58
- 90% CI riddle The Outlaw Torn 2012-12-20 11:23
- 90% CI riddle Dr_Dan 2012-12-20 09:45
- 90% CI riddle The Outlaw Torn 2012-12-19 07:49
- ISRDr_Dan 2012-11-29 16:30
Ing. Helmut Schütz